What is NDC 0781-5284?

0781-5284 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, chewable, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine Hydrochloride?

104 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cetirizine Hydrochloride NDC 0781-5284

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5284Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5284Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0781-5284-64	00781528464	30 BLISTER PACK in 1 CARTON (0781-5284-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06)Marketed from Feb 14, 2008

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cetirizine Hydrochloride
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 10 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078692
Marketing start: Feb 14, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0781-5284_4b5cb5f2-f046-4a6f-abfc-da4280fce674SPL ID 4b5cb5f2-f046-4a6f-abfc-da4280fce674SPL set ID a814a06b-96ed-4403-bbd7-fc1142988b50RxCUI 1014674UNII 64O047KTOA
Pharmacologic class: Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400781528464 followed by a unit qualifier and the quantity

Package 00781-5284-64. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 30, 2025.

Indications (excerpt from the label)

Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5284

What is NDC 0781-5284?: 0781-5284 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, chewable, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine Hydrochloride.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine Hydrochloride?: 104 other product NDCs are listed under this name. See all Cetirizine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cetirizine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	First Nation Group, LLC	81469-353	81469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-017	48433-0017-20
Cetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Advagen Pharma Ltd.,	72888-480	72888-0480-01
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4072	68788-4072-0368788-4072-0668788-4072-09
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Bionpharma Inc.	69452-426	69452-0426-5569452-0426-88
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-357	57237-0357-1257237-0357-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-358	57237-0358-1257237-0358-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-2261037-0480-2361037-0480-24+2 more
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Bi-Mar	37835-611	37835-0611-1437835-0611-3537835-0611-90
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	Advanced Rx LLC	80513-731	80513-0731-0580513-0731-12

All 105 Cetirizine Hydrochloride NDCs

Other NDCs under ANDA 078692

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078692
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	Tablet, ChewableOral	Sandoz Inc	0781-5283